BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG

    MDR report key: 662168 · Received August 29, 2005

    Report

    Report Number
    1423500-2005-01379
    Event Type
    Malfunction
    Date Received
    August 29, 2005
    Date of Event
    July 31, 2005
    Report Date
    July 31, 2005
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A HOME PT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER FOR A CHECK FINAL LINE MESSAGE THAT APPEARED ON THE DISPLAY OF THE HOMECHOICE MACHINE DURING THE DWELL CYCLE OF HER PERITONEAL DIALYSIS THERAPY. PER INITIAL REPORT, THE HOME PT DISCONNECTED A SUPPLY BAG FROM THE SUPPLY LINE OF THE HOMECHOICE MACHINE ND RECONNECTED THE SUPPLY BAG TO ANOTHER SUPPLY LINE. BAXTER'S TECHNICAL CENTER ASSISTED THE HOME PT IN ENDING THE THERAPY EARLY. NO PT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE 4-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR